Take Fat Out Of Claims, U.s. Says

July 21, 2000|By GLENN SINGER Business Writer

The U.S. Federal Trade Commission said Thursday it will seek full refunds for women in America who bought Cellasene to remove cellulite from their thighs and buttocks -- and that could amount to $75 million or more.

The FTC filed suit against Cellasene distributor Rexall Sundown late Wednesday, accusing the Boca Raton company of making false advertising claims that the product works. The agency cited ads in newspapers, magazines and on the Internet.

Rexall Sundown, now a subsidiary of Royal Numico N.V. of The Netherlands, denied the charges.

The FTC's suit, filed in U.S. District Court for the Southern District of Florida, seeks an injunction to halt the advertising claims and asks the court to order refunds to consumers.

"Rexall made unsubstantiated claims that Cellasene eliminates or substantially reduces cellulite," said attorney Darren Bowie, assistant director of the FTC's division of advertising practices. "The company also falsely represented that it had clinical evidence showing the product worked."

Rexall Sundown pledged to "vigorously defend the suit," which could cost the company $75 million or more based on sales and projected sales through the end of this year. The dietary supplement was introduced nationally in March 1999.

The case, assigned to U.S. District Judge Wilkie Ferguson in Fort Lauderdale, promises to be a battle of expert witnesses if it goes to trial.

"We have an outside expert prepared to testify, and it's likely we will have more by the time we go to trial," Bowie said.

He also said the FTC plans to interview and possibly depose Dr. Brian Berman, a dermatologist at the University of Miami whose recent clinical trial on Cellasene produced no results because the participants did not comply with study guidelines.

Rexall Sundown is expected to parade out its experts, including Dr. Enzo Berardesca, an Italian researcher whose work with the supplement provided an early foundation for efficacy claims. Cellasene is made by an Italian company, Medestea International.

Another probable witness is Debbie DeSantis, a registered pharmacist, daughter of Rexall Sundown founder Carl DeSantis and the company's senior vice president for product development.

In a statement issued Wednesday, Debbie DeSantis said, "The commission's action completely ignores the sound scientific research into the effectiveness of Cellasene," which "was designed and formulated by one of the world's leading herbal-pharmaceutical extract companies with foremost experience in cellulite research."

DeSantis said the FTC rebuffed efforts to have Rexall Sundown experts meet with investigators to answer questions and address the issues involved. FTC attorney Bowie said he did not know of any such overtures.

According to the FTC and Rexall Sundown, women were advised to take three Cellasene geltabs a day for eight weeks and then a maintenance dose of one a day for the next eight weeks. The initial eight-week regimen cost between $180 and $240, the FTC said.

If the FTC wins and the judge orders refunds, Bowie said, the FTC probably would accept affidavits from women who did not keep packages of Cellasene or proof of purchase.

The product is formulated from extract of grape seed, fish oil, soya lecithin, sweet clover, borage seed oil and bladderwrack extract. It also contains iodine, which can cause problems for those with thyroid conditions and those taking blood thinners.

The geltabs are supposed to increase the body's metabolic rate and improve blood circulation, thereby helping to eliminate fluids and trapped fat.

Rexall Sundown has said many women were not repeat customers because they did not see results right away. The FTC claims many of them never would.

In another court filing, Dorothy Greenfield of Boca Raton filed suit against Rexall Sundown in Palm Beach County Circuit Court on Thursday, claiming the company deceived consumers by misrepresenting Cellasene's ability to reduce cellulite.

Greenfield is seeking class-action status in the case.

Glenn Singer can be reached at gsinger@sun-sentinel.com or 561-243-6612.